MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 3 ACCOLADE II BROACH; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 1020-5203

Device Problems Break (1069); Fracture (1260); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2016

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

When applying the accolade ii rasp # 3 and detaching the femoral reel handle, the color coding was in the surgical area.The color coding was removed by a clamp.

Manufacturer Narrative

An event regarding crack/fracture involving an accolade broach was reported.The event was confirmed.Method & results: -device evaluation and results: material analysis of the returned device was performed which concluded that "the color coded polymer insert of the broach fractured in overload.The direction of fracture of the polymer insert was consistent with loading from an unknown side force that also deformed the rim hole of the broach.No material or manufacturing defects were observed on the surfaces examined." -medical records received and evaluation: not performed as patient factors did not contributed to the event.-device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there has been no other event for the lot referenced.Conclusions: the reported event was confirmed as per material analysis performed on the returned device which concluded that the color coded polymer insert of the broach fractured in overload.The direction of fracture of the polymer insert was consistent with loading from an unknown side force that also deformed the rim hole of the broach.No material or manufacturing defects were observed on the surfaces examined.No further investigation is required at this time.If the additional information will be received, this investigation will be reopened and re-evaluated.

Event Description

When applying the accolade ii rasp # 3 and detaching the femoral reel handle, the color coding was in the surgical area.The color coding was removed by a clamp.

• Brand Name: SIZE 3 ACCOLADE II BROACH
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6115301
• MDR Text Key: 60688146
• Report Number: 0002249697-2016-03661
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K153345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1020-5203
• Device Lot Number: B6HCY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR